Low-Dose Naltrexone Combined With Bupropion to Stop Smoking With Less Weight Gain

Smoking Clinical Trial

Official title:

Naltrexone & Bupropion to Stop Smoking With Less Weight Gain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00129246
• Other study ID #: NIAAAOMA15632-B
• Secondary ID: P50AA015632NIH G
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 2004
• Est. completion date: December 2005

Study information

• Verified date: November 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will test a combination of the drugs naltrexone and bupropion with weight-concerned smokers to investigate whether or not this combination of drugs improves smoking cessation quit rates and minimizes post quit weight gain.

Description:

This is an open label smoking cessation clinical trial of 25 mg naltrexone with 300 mg bupropion sustained-release (SR) in six male and fourteen female participants. This pilot study is being conducted to determine:

• effect size estimates for smoking cessation and post-cessation weight gain, which will be used to compute the sample size needed for a large-scale clinical trial; and

• compliance with a combination of 25 mg naltrexone and 300 mg bupropion SR. In addition to examining the sample in this study, the investigators plan to compare this sample to a sample of matched controls.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Ages 18 and older

• Willingness and ability to give written consent

• Smoking at least 10 cigarettes per day for at least 1 year

• Baseline expired carbon-monoxide level of at least 10 ppm

• Weigh at least 100 lbs.

• English-speaking

• One person per household

• At least 1 prior quit attempt

• Concern about gaining weight. This will be assessed using a questionnaire that will provide a rating system to determine qualified participants.

Exclusion Criteria:

• Pregnant or nursing women or women attempting to conceive

• Serious current neurologic, psychiatric or medical illness, including unstable cardiac, hepatic, or renal disease and diabetes and hypertension

• Current alcohol dependence

• Current use of opiates, and/or a urine toxicology screen positive for opiates

• Chronic pain conditions necessitating opioid treatment (naltrexone, an opioid antagonist will make these medications ineffective)

• Evidence of significant hepatocellular injury as evidenced by AST or ALT >3 x normal or elevated bilirubin

• History of cirrhosis

• Body mass index (BMI) greater than 35

• History of anorexia nervosa or bulimia

• Current major depression

• Currently taking Toprol-XL (or metoprolol succinate)

• History of seizure disorder or serious brain injury

• Current use of smokeless tobacco, pipes, cigars, nicotine gum, nicotine patch, nicotine inhaler, nicotine lozenge, nicotine nasal spray, or bupropion

• Previous hypersensitivity to bupropion

• Patients requiring concomitant therapy with any psychotropic drug

• Participation in the Framing Messages for Smoking Cessation With Bupropion study (HIC#: 10880)

Related Conditions & MeSH terms

• Nicotine Dependence
• Smoking
• Tobacco Use Disorder
• Weight Gain

Intervention

Drug:
• Naltrexone
Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.
• Bupropion
Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period.

Locations

Country	Name	City	State
United States	Yale University School of Medicine Substance Abuse Treatment Unit	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Toll BA, Leary V, Wu R, Salovey P, Meandzija B, O'Malley SS. A preliminary investigation of naltrexone augmentation of bupropion to stop smoking with less weight gain. Addict Behav. 2008 Jan;33(1):173-9. Epub 2007 Jun 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation	Smoking cessation is defined as the number of patients that displayed continuous 6-week abstinence from the quit date.	Week 6
Primary	Point Prevalence Abstinence	Point prevalence abstinence is defined as the number of patients reporting point prevalence abstinence over the last 7 days.	Week 6
Primary	Weight Gain	Weight gain for for the entire sample in pounds at 6 weeks.	Week 6
Secondary	Weight Gain Abstinent Participants	Weight gain (in pounds) for the patients that were continuously abstinent at 6 weeks.	Week 6